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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01689454
Other study ID # EG48BSept12
Secondary ID EG2
Status Enrolling by invitation
Phase Phase 3
First received September 10, 2012
Last updated September 17, 2012
Start date September 2012
Est. completion date September 2013

Study information

Verified date September 2012
Source Biogenesi
Contact n/a
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Observational

Clinical Trial Summary

Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss.

Couples requiring IVF treatment and with a past experience of implantation failure will be included in the study.

Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions.

Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date September 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- women experiencing at least two (maximum 4) failures of implantation after ART treatments (with elective embryo transfer)

Exclusion Criteria:

- Frozen spermatozoa

- Frozen oocytes

- women PCO and PCOS

- women with previous pregnancy, miscarriage or biochemical pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Biogenesi Reproductive Medicine Centre Monza MB

Sponsors (1)

Lead Sponsor Collaborator
Biogenesi

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Agerholm I, Loft A, Hald F, Lemmen JG, Munding B, Sørensen PD, Ziebe S. Culture of human oocytes with granulocyte-macrophage colony-stimulating factor has no effect on embryonic chromosomal constitution. Reprod Biomed Online. 2010 Apr;20(4):477-84. doi: 10.1016/j.rbmo.2009.12.026. Epub 2009 Dec 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ongoing Pregnancy Rate after 12 weeks of gestation 12 weeks after conception No
Secondary Ongoing Implantation Rate after 12 weeks of gestation 12 weeks after conception No
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